A Two Part, Open-label Study to Evaluate the Safety and Effectiveness of ABT-450/r/ABT-267 or ABT-450/r/ABT-267 and ABT-333 Given With or Without a Drug Called Ribavirin in People With Both Hepatitis C Virus Genotype 1 or 4 Infection and Human Immunodeficiency Virus, Type 1 Infection (TURQUOISE-I)

The purpose of this study is to assess the safety and efficacy of ombitasvir/paritaprevir/ritonavir with and without dasabuvir coadministered with and without ribavirin for 12 and 24 weeks in adults with genotype 1 or 4 Chronic Hepatitis C Virus Infection with Human Immunodeficiency Virus, Type 1 coinfection.

A Multipart, Open-label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With and Without Dasabuvir Coadministered With and Without Ribavirin in Adults With Genotype 1 or 4 Chronic Hepatitis C Virus Infection and Human Immunodeficiency Virus, Type 1 Coinfection (TURQUOISE-I)

Percentage of subjects in genotype 1 Analysis Group 1 in Part 2 achieving sustained virologic response 12 weeks post-treatment (SVR12) compared to the historical SVR12 rate for sofosbuvir plus ribavirin as reported in the PHOTON-1 study [ Time Frame: 12 weeks after the last actual dose of study drug ] [ Designated as safety issue: No ]

Hepatitis C Virus ribonucleic acid less than the lower limit of quantification

Secondary Outcome Measures:

The percentage of subjects in genotype 1 Analysis Group 2 of Part 2 achieving sustained virologic response 12 weeks post-treatment (SVR12) compared to the historical rate for sofosbuvir plus ribavirin [ Time Frame: 12 weeks after last dose of study drug ] [ Designated as safety issue: No ]

Hepatitis C Virus ribonucleic acid less than the lower limit of quantification

The percentage of Part 1a subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in the 24-week treatment group compared to the 12-week treatment group using Fisher's exact test [ Time Frame: 12 weeks after last dose of study drug ] [ Designated as safety issue: No ]

Hepatitis C Virus ribonucleic acid less than the lower limit of quantification

The percentage of subjects of Part 1b subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in the darunavir once-daily arm compared to the darunavir twice-daily arm using Fisher's exact test [ Time Frame: 12 weeks after last dose of study drug ] [ Designated as safety issue: No ]

Hepatitis C Virus ribonucleic acid less than the lower limit of quantification

Hepatitis C Virus ribonucleic acid less than the lower limit of quantification

The percentage of genotype 4 subjects in Part 2 achieving sustained virologic response 12 weeks post-treatment (SVR12) by arm and overall [ Time Frame: 12 weeks after last dose of study drug ] [ Designated as safety issue: No ]

Hepatitis C Virus ribonucleic acid less than the lower limit of quantification

Percentage of subjects with on treatment Hepatitis C Virus virologic failure during the Treatment Period for each arm in Part 1, set of all subjects in Part 1b, the genotype 1 Analysis Group 1 and 2 in Part 2, the GT4 Analysis Group by arm and overall [ Time Frame: up to 12 or 24 weeks based on treatment duration ] [ Designated as safety issue: No ]

The percentage of subjects with Hepatitis C Virus post-treatment relapse (analyses performed as described for secondary endpoint 7). [ Time Frame: within 12 weeks after the last dose of study drug ] [ Designated as safety issue: No ]

The percentage of subjects with confirmed quantifiable Hepatitis C Virus ribonucleic acid among subjects with unquantifiable Hepatitis C Virus ribonucleic acid at the end of treatment

Percentage of subjects with plasma HIV-1 RNA suppression at end of treatment and 12 weeks post-treatment (analyses performed as described for secondary endpoint 7) and comparison of the darunavir once-daily and twice-daily arms in Part 1b [ Time Frame: up to 12 weeks after the last dose of study drug ] [ Designated as safety issue: No ]

ABT-450/r/ABT-267 and ABT-333 for 12 weeks for subjects receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily.

Drug: ABT-450/r/ABT-267

Tablet

Other Name: Ombitasvir/Paritaprevir/Ritonavir

Drug: ABT-333

Tablet

Other Name: Dasabuvir

Experimental: ARM F

ABT-450/r/ABT-267 and ABT-333 for 12 weeks for subjects receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily.

Drug: ABT-450/r/ABT-267

Tablet

Other Name: Ombitasvir/Paritaprevir/Ritonavir

Drug: ABT-333

Tablet

Other Name: Dasabuvir

Experimental: ARM G

ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for subjects receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily.

Drug: ABT-450/r/ABT-267

Tablet

Other Name: Ombitasvir/Paritaprevir/Ritonavir

Drug: ABT-333

Tablet

Other Name: Dasabuvir

Drug: Ribavirin (RBV)

Tablet

Experimental: ARM H

ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for subjects receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily.

Drug: ABT-450/r/ABT-267

Tablet

Other Name: Ombitasvir/Paritaprevir/Ritonavir

Drug: ABT-333

Tablet

Other Name: Dasabuvir

Drug: Ribavirin (RBV)

Tablet

Experimental: ARM I

ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 12 weeks for subjects receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily.

Drug: ABT-450/r/ABT-267

Tablet

Other Name: Ombitasvir/Paritaprevir/Ritonavir

Drug: ABT-333

Tablet

Other Name: Dasabuvir

Drug: Ribavirin (RBV)

Tablet

Experimental: ARM J

ABT-450/r/ABT-267 and ABT-333 coadministered with ribavirin (RBV) for 24 weeks for subjects receiving any of the following: atazanavir once-daily, raltegravir twice-daily, dolutegravir once-daily or twice-daily.

Evidence of HCV genotype other than genotype 1 or genotype 4 during screening.

Receipt of any other investigational or commercially available anti-HCV agents (for example, telaprevir, boceprevir, simeprevir, daclatasvir and ledipasvir) with the exception of interferon (including pegylated-interferon alfa-2a or alfa-2b), sofosbuvir and ribavirin.

Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-450, ABT-267, ABT-333, ritonavir or ribavirin.

Chronic human immunodeficiency virus, type 2 (HIV-2) infection.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01939197